MAUDE Adverse Event Report: SISTEMAS MEDICOS ALARIS, S.A. DE C.V. BD ALARIS¿ LVP 20D 3SS CV BV; INTRAVASCULAR ADMINISTRATION SET

Model Number	11522558
Medical Device Problem Codes	Leak/Splash (1354); Material Separation (1562)
Health Effect - Clinical Code	Chemical Exposure (2570)
Date of Event	09/07/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.
Event or Problem Description
It was reported while using a bd alaris¿ lvp 20d 3ss cv bv leakage occurred.There was no report of patient impact.The following information was provided by the initial reporter: i placed the drug on the iv pole and the spike on the primary tubing that goes into the drug fell out spontaneously and leaked a significant amount of drug onto myself, the pump, and the floor.I cleaned the area and had pharmacy make another bag for the patient to receive and disposed of the one that leaked.
Additional Manufacturer Narrative
Investigation summary: the customer reported the set separated and leaked, and returned a photo of the failure location.The photo verifies the complaint of separation as a lower fitment solvent based connection issue.The root cause cannot be determined without the physical sample investigation.Device history record review for model 11522558 lot number 22095036 was performed.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.
Event or Problem Description
It was reported while using a bd alaris¿ lvp 20d 3ss cv bv leakage occurred.There was no report of patient impact.The following information was provided by the initial reporter: i placed the drug on the iv pole and the spike on the primary tubing that goes into the drug fell out spontaneously and leaked a significant amount of drug onto myself, the pump, and the floor.I cleaned the area and had pharmacy make another bag for the patient to receive and disposed of the one that leaked.

• Brand Name: BD ALARIS¿ LVP 20D 3SS CV BV
• Common Device Name: INTRAVASCULAR ADMINISTRATION SET
• Manufacturer (Section D): SISTEMAS MEDICOS ALARIS, S.A. DE C.V.; blvd. insurgentes no. 20351; parque industrial el florido; tijuana
• Manufacturer (Section G): SISTEMAS MEDICOS ALARIS, S.A. DE C.V.; blvd. insurgentes no. 20351; parque industrial el florido; tijuana
• Manufacturer Contact: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 16160928
• Report Number: 9616066-2022-02204
• Device Sequence Number: 20577398
• Product Code: FPA
• UDI-Device Identifier: 50885403232303
• UDI-Public: (01)50885403232303
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K944320
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/15/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Other
• Device Expiration Date: 09/01/2025
• Device Model Number: 11522558
• Device Catalogue Number: 11522558
• Device Lot Number: 22095036
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/21/2022
• Supplement Date Received by Manufacturer: 02/15/2023
• Initial Report FDA Received Date: 01/13/2023
• Supplement Report FDA Received Date: 03/05/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/29/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown